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Sanofi Group Senior Corporate Counsel in Cambridge, Massachusetts

The Senior Counsel in the Global Industrial Affairs Legal team will act as the primary legal point of contact for the Global Quality organization supporting quality and regulatory activities and teams across all Sanofi GBUs (General Medicines, Specialty Care, Vaccines and External Manufacturing) supporting the Global IA organization on a wide range of issues including compliance and enforcement, quality alert management (product recalls), supply chain security, regulatory inspections and GQA audits and digital transformation. Based on his/her experience rooted in a deep understanding of US and foreign food, drug and medical device laws and policies, this position will provide long term strategic advice, guide the business through regulatory GxP inspections, investigations, civil and criminal enforcement actions, and other regulatory challenges, as well as proactively support day to day initiatives. This position will also act as the main legal point of contact to support US based industrial activities and teams.

This is a broad expert and business lawyering role that includes strategic counseling. Areas of activity will include:

  • Providing counsel on Current Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Quality System regulation, data integrity issues, product labeling, Drug Supply Chain Security Act implementation, product recalls and adverse events reporting matters

  • Providing strategic advice to support Sanofi in achieving and maintaining compliance with complex FDA requirements

  • Supporting GMP and data integrity assessments across global network of IA sites

  • Preparing sites across global IA network for inspections by FDA and other regulatory health authorities (ANSM, ANVISA, China FDA, EMA) as well as for pre-approval and pre-licensing inspections

  • Assisting with responding to FDA enforcement actions related to GMP, QSR and data integrity issues

  • Assistance in drafting responses to FDA Form 483s, Warning Letters, import alerts, investigations and other FDA enforcement actions

  • Providing advice in internal compliance investigations

  • Preparing recall communications

  • Representing Sanofi in FDA consent decree negotiations and at regulatory meetings

  • Advising on CMC-related issues in IND, NDA, and BLA submissions

  • Providing strategic guidance concerning marketing applications and CMC issues

  • Providing regulatory and compliance guidance regarding digital health and AI technologies

  • Advising the Global IA organization on strategies to protect trade secrets and confidential commercial information from public disclosure under the Freedom of Information Act (FOIA) and FDA regulations

  • Providing counsel on FDA regulatory issues related to corporate sales and reorganizations

  • Acting as primary legal point of contact for US UA sites (across GBUs)

Business expects prompt responses with their requests, and one of the challenges for this Senior Counsel for Global Industrial Affairs will be to prioritize numerous, and sometimes conflicting, requests for assistance and offer superior service in a timely, thoughtful and complete manner. This position will need to be confident and comfortable with senior decision makers and working independently across Sanofi at multiple levels.

The Senior Counsel for Global Industrial Affairs will provide input on complex and sensitive regulatory and business issues and will advise his/her business partners in a manner that advances the company’s strategy while addressing legal and regulatory risks and preserving and protecting the company’s integrity and reputation.

The Senior Counsel in Global Industrial Affairs operates with limited supervision, and therefore requires a very high level of balanced judgment and a strong ability to independently discern and establish priorities. Agility and willingness to learn about various subject matters (both from a legal and business perspective) are expected and highly valued.

Position to be based in Cambridge, Massachusetts or Swiftwater, Pennsylvania.

JOB QUALIFICATIONS:

  • BA/BS, Juris Doctorate degree from an accredited law school

  • Minimum of 10 – 12 years of legal experience at a law firm working on healthcare related matters and/or working inhouse with a pharma/biotech company

  • Must have solid experience dealing with the FDA and other regulatory health authorities (ANSM, ANVISA, China FDA, EMA)

Professional Skills/Attributes:

  • Excellent written and oral communication skills

  • Team player with a commitment to developing strong collaborative relationships with legal colleagues, clients and cross-functional teams

  • Project management

  • Commitment to proactively identifying opportunities for improvement and engaging with appropriate stakeholders to propose solutions

  • Solutions-oriented; business-oriented

  • Self-motivated, able to work independently, reliable, responsive, and accountable to deliver results

  • High level of professionalism; strong interpersonal skills

  • Proven ability/interest in working across a broad range of subject matter areas

  • Ability to handle multiple responsibilities and priorities simultaneously and still meet high quality and timeliness standards under pressure

  • Willingness to flex job responsibilities and learn new areas

  • Management and interpersonal skills

  • Sound judgment and commitment to ethical conduct

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Fully vaccinated, according to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#LI-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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